BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INSERT #6 11MM

    MDR report key: 3002503 · Received March 13, 2013

    Report

    Report Number
    0002249697-2013-00964
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    April 1, 2011
    Report Date
    February 21, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). AN EVENT REGARDING PAIN INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. A REVIEW OF THE PROVIDED MEDICAL RECORDS AND X-RAYS BY A CLINICAL CONSULTANT INDICATED: X-RAY COPIES, ALL OF WHICH ARE DATED OFF THE FILMS, INCLUDE A SERIES NOTED AS (B)(4) 2010, AND INCLUDES AN AP AND LATERAL OF THE LEFT KNEE DEMONSTRATING A CEMENTED LEFT TOTAL KNEE ARTHROPLASTY IN NOMINAL POSITION WITH SKIN STAPLES IN SITU. A SERIES NOTED TO BE (B)(4) 2011 IS AN AP AND LATERAL OF THE LEFT KNEE, AND THERE IS NO CHANGE EXCEPT FOR A SLIGHTLY THICKER INSERT. THERE IS NO EVIDENCE OF FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING OR MATERIALS BEING RESPONSIBLE FOR THIS CLINICAL SITUATION. REFLEX SYMPATHETIC DYSTROPHY SHOULD BE RULED OUT AS A POSSIBLE CAUSE OF THE PERSISTENT SYMPTOMS IN THIS CASE. DEVICE HISTORY REVIEW INDICATED THERE HAVE BEEN NO REPORTED DISCREPANCIES FOR THE REFERENCED LOT. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. REVIEW OF X-RAYS AND MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED THE TRIATHLON KNEE SYSTEM TO BE IN NOMINAL POSITION AND THERE IS NO EVIDENCE OF FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING OR MATERIALS BEING RESPONSIBLE FOR THIS CLINICAL SITUATION.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN STRYKER LEFT KNEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE PATIENT REPORTS HAVING REVISION SURGERY ON THE LEFT KNEE IN (B)(6) 2011. THE PATIENT CONTINUES TO HAVE THE SAME PROBLEMS HE WAS HAVING PRIOR TO THE REVISION. THE PATIENT REPORTS PAIN, KNOCKING AND CLICKING IN THE KNEE. PATIENT EXPERIENCES PAIN WHEN WALKING, STANDING AND LIFTING THE KNEE.

    Description of Event or Problem · 1

    THE PATIENT REPORTS HAVING REVISION SURGERY ON THE LEFT KNEE IN (B)(6) 2011. THE PATIENT CONTINUES TO HAVE THE SAME PROBLEMS HE WAS HAVING PRIOR TO THE REVISION. THE PATIENT REPORTS PAIN, KNOCKING AND CLICKING IN THE KNEE. PATIENT EXPERIENCES PAIN WHEN WALKING, STANDING AND LIFTING THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104946 X3 TRIATHLON CS INSERT #6 11MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH LCF426

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other